• Return to search results
• Start new search

Investigator(s):
Daniel Fowler, M.D. Principal Investigator Phone: 301-435-8641 Fax: 301-451-5578 dhfowler@helix.nih.gov
Referral Contact(s):
Zetta Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-451-5578 bblacklock@mail.nih.gov

---

Primary Eligibility:

• Diagnosis of metastatic renal cell carcinoma
• Age 18–75 years
• Prior nephrectomy (either partial or complete resection)
• Progressive disease after prior treatment with sorafenib, sunitinib, or temsirolimus
• Patients eligible for high-dose interleukin-2 (IL-2) and who elect to receive this therapy must have progressive disease after treatment with IL-2 AND must also have progressive disease after treatment with sorafenib, sunitinib, or temsirolimus
• No active CNS involvement
• 6/6 HLA-matched (A, B, DR) sibling donor available
• Karnofsky performance status 80–100%
• Left ventricular ejection fraction > 40% by MUGA or ECHO
• DLCO > 50% of expected value (hemoglobin corrected)
• Creatinine clearance ≥ 40 mL/min
• Total bilirubin < 2.5 mg /dL
• Serum ALT and AST ≤ 2.5 x upper limit of normal (ULN) (5 x ULN if due to liver involvement)
• Not pregnant or nursing; fertile patients must use effective contraception during and for at least 1 year after transplantation
• No active infection that does not respond to antimicrobial therapy
• No HIV infection
• No chronic active hepatitis B
• Hepatitis B core antibody positive allowed
• No history of psychiatric disorder that would preclude compliance with study or that would preclude giving informed consent

---

Study Outline:

This is a multicenter study.

• Induction therapy:
• Patients receive oral cyclophosphamide once daily for 21 days; dose-adjustments based upon bi-weekly evaluation of absolute lymphocyte count
• Patients will also receive IV Pentostatin on Days 1, 8, and 15
• Allogeneic hematopoietic stem cell transplantation:
• Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on Day 0 (approximately 24 days after initiation of induction therapy)
• Patients receive G-CSF SC beginning on Day 0 and continuing until blood counts recover
• Patients receive high-dose oral sirolimus on Day -2 through Day 60 for GVHD prophylaxis
• Patients receive donor Th2 cells IV on Days 0, 14, and 45
• Patients are followed twice weekly for 100 days post-transplantation, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter for up to 5 years

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 5/27/09
Updated: 9/22/09